Seattle Genetics and Bristol-Myers Squibb have initiated a phase 1/2 clinical trial of Adcetris (brentuximab vedotin) in combination with Opdivo (nivolumab) in patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL).
The trial includes patients with diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
This is the second of two trials being conducted under a previously announced clinical trial collaboration agreement between Bristol-Myers Squibb and Seattle Genetics. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a marker expressed on Hodgkin lymphoma (HL) and several types of NHL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Recent preclinical data suggest that Adcetris causes immunogenic cell death of tumour cells, providing rationale for combination with Opdivo, a human antibody that targets and inhibits the programmed death receptor-1 (PD-1), resulting in T-cell activation.
Trial will evaluate the safety, tolerability and ORR of Adcetris and Opdivo
Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics, said, “This study is a part of a broad development programme that includes more than 70 ongoing clinical trials evaluating Adcetris in multiple lines of therapy for Hodgkin and non-Hodgkin lymphoma and as part of novel combinations that could result in improved clinical benefit with manageable safety profiles. Our goal is to establish Adcetris as the foundation of care for CD30-expressing lymphomas.”
The Phase 1/2 trial will consist of a Phase 1 dose evaluation portion followed by a single-arm Phase 2 portion that will expand enrolment to treat disease-specific cohorts with relapsed or refractory DLBCL, PTCL or CTCL at the recommended dose level and treatment schedule. The primary endpoints are safety, tolerability and objective response rate (ORR) of the combination of Adcetris with Opdivo. The secondary endpoints include duration of response, complete response rate with the combination regimen, duration of complete response, progression-free survival and overall survival.
